Following a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of cochineal, carminic acid, carmines (E 120) as a food additive.
The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the information available following public calls for data. The Panel noted that not all original studies on which previous evaluations were based were available for re-evaluation by the Panel. To assist in identifying any emerging issue or any information relevant for the risk assessment, EFSA outsourced a contract to deliver an updated literature review on toxicological endpoints, dietary exposure and occurrence levels of cochineal extract, carminic acid and carmines (E 120), which covered the period from the beginning of 2013 up to the end of 2014. Further updates have been performed by the Panel.
Cochineal, carminic acid and carmines (E 120) are red anthraquinone dyes authorised as food additives in the European Union (EU), in accordance with Annex II to Regulation (EC) No 1333/2008.
Cochineal, carminic acid and carmine (E 120) have most recently been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2000, which set new specifications, and by the Scientific Committee for Food (SCF) in 1983. Both committees established an Acceptable Daily Intake (ADI) of 5 mg/kg body weight (bw)/day. The JECFA ADI, established in 1982 for carmines (formerly cochineal, carmines and carminic acid), includes ammonium carmine or the equivalent calcium, potassium or sodium salts. For the SCF, the ADI applies to cochineal (carmines), without further details being specified. The 1981 JECFA evaluation specifically excluded the lithium salt, considering it as not acceptable for food additive use.
Specifications have been defined in Commission Regulation (EU) No 231/2012 and by JECFA in 2000. In the EC specifications, cochineal, carminic acid and carmine colours are defined as having not less than 2.0 % carminic acid in the extracts and not less than 50 % carminic acid in the chelates. The remaining material (50 to 80 %) is not precisely specified, being only described as cations that may be present in excess in the colour and also maybe containing proteinaceous material derived from the source insect, together with free carminate or a small residue of unbound aluminium cations. The Panel noted thus that the specifications of carmines need to be updated with respect to the percentage of material not accounted for. The Panel noted that the title of the EC specifications, “E 120, cochineal, carminic acid, carmines”, does not adequately correspond to the specified food colour. The Panel also noted that the actual EC specifications for cochineal extract, carminic acid, carmines do not include limits for the protein content, total ash, residual solvents, or insoluble matter. The Panel considered that further indication on the proportions or percentages of these components, particularly the protein content and the molecular weight of the key allergenic proteins, in the commercial product should be required. Furthermore, the Panel considered that the maximum limits for toxic elements (arsenic, lead, mercury and cadmium) present as impurities in the EC specifications for E 120 should be revised in order to ensure that E 120 used as a food additive will not be a significant source of exposure to these toxic elements in food.
The Panel noted that the term Cochineal per se is a description of the ground bodies of the female insect Dactylopius coccus Costa before extraction, and to the knowledge of the Panel, this material is not used as a food colour. Furthermore, the composition of cochineal extracts is not well defined, and, as described further, the established ADI was based on studies using carmine with a defined amount of carminic acid as test material. Therefore, the Panel proposes that the current title of the food additive (“E 120 cochineal, carminic acid, carmines”) should be revised to “E 120 cochineal extract, carminic acid and carmines” which would more accurately reflect the material used. Carmines should meet existing carmines EC specifications including those concerning the content of ≥ 50 % carminic acid.
No studies on absorption, distribution, metabolism or excretion of cochineal extract, carminic acid or carmines were available for this evaluation. However, both the ionisation properties of carminic acid and indirect evidence from toxicological studies suggest that these compounds can be absorbed to some extent as suggested by the accumulation of colour in tissues and the red colouring of urine reported in rats treated with ammonium carmine.
Short-term and subchronic studies conducted in rats and mice did not show toxicological potential.
Two long-term studies in rats and mice investigated the carcinogenic potential of carmine and cochineal extract, respectively. The rat study on carmine reported significantly higher incidences of acinar hyperplasia and duct ectasia of the mammary tissue in female rats given carmines, at all doses, compared with controls. The mammary hyperplasia seen in the rat study was not reported in the mouse study performed with cochineal extract, and the general pattern of tumour incidence in the mouse study was not significantly different from that of the controls. After considering all the available information, the Panel considered that the incidences of mammary hyperplasia reported in the rat study were not treatment related. Overall, the Panel concluded that carmine is not carcinogenic.
No adverse effects were reported in reproductive and developmental toxicity studies in rats and mice when tested at doses of up to 1 000 mg carmine/kg bw/day or 3 000 mg cochineal extract/kg bw/day. Overall, the Panel considered that the available data suggest that cochineal extract and carmine do not show reproductive or developmental toxicity.
The available information regarding genotoxicity indicates that carminic acid is not genotoxic, and, by read-across, carmine is also considered non-genotoxic.
The Panel concluded that the present dataset does not give reason to revise the ADI of 5 mg carmine (containing approximately 50 % carminic acid)/kg bw allocated by the SCF in 1983, but considered that for clarification this ADI should only apply to cochineal extract and to carmine. The Panel concluded that this ADI should be expressed as carminic acid content, and this would correspond to 2.5 mg carminic acid/kg bw/day.
The Panel noted that the composition of cochineal tested in the toxicological studies available is not well defined and that, to the knowledge of the Panel, Cochineal (the ground bodies of the female insect D. coccus Costa before extraction) is not used as a food colour in the EU. Furthermore, taking into account that the ADI was derived from toxicological studies using carmine as test material with defined amounts of carminic acid (46 to 56 % carminic acid), which match those specified in the EU specifications, the Panel concluded that based on available information, the ADI of 5 mg/kg bw/day does not apply to Cochineal (the ground bodies of the female insect). Lithium salts of carminic acid are not covered by this ADI.
Using the “maximum level exposure assessment scenario”, the mean exposure to E 120 from its use as a food additive ranged from 0.1 mg/kg bw/day in infants to 3.9 mg/kg bw/day in toddlers, while the high exposure using this scenario ranged from 0.3 mg/kg bw/day in infants to 6.7 mg/kg bw/day in toddlers.
Using the refined brand-loyal exposure assessment scenario, the mean exposure to E 120 from its use as a food additive ranged from 0.1 mg/kg bw/day in infants, adolescents, adults and the elderly to 2.1 mg/kg bw/day in toddlers. The high exposure to E 120 using this scenario ranged from 0.2 mg/kg bw/day in the elderly to 4.7 mg/kg bw/day in toddlers.
Using the refined non-brand-loyal exposure assessment scenario, the mean exposure to E 120 from its use as a food additive ranged from 0.02 mg/kg bw/day in infants to 0.6 mg/kg bw/day in toddlers. The high exposure to carminic acid, carmines (E 120) from its use as food additive using this scenario ranged from 0.1 mg/kg bw/day in infants, adolescents, adults and the elderly to 1.1 mg/kg bw/day in toddlers.
Overall, refined exposure estimates for the non-brand-loyal scenario for infants, toddlers, children adolescents, adults and the elderly show that exposure to E 120 is below the ADI of 2.5 mg carminic acid/kg bw/day for all population groups.
The Panel considered that the ADI of 5 mg/kg bw/day does not cover minimum sensitising or eliciting doses for susceptible individuals. Allergic reactions have been associated with exposure to cochineal extract and carmines. Both substances are able to trigger acute hypersensitivity reactions, such as Quincke’s oedema, dyspnoea and bronchospasm, in sensitised individuals, and can cause severe anaphylactic reactions. In addition, chronic hypersensitivity symptoms, such as rhinoconjuctivitis and asthma, have also been associated with occupational exposure to carmine. The reported effects are likely to be the consequence of allergic reactions involving an immunoglobulin E (IgE)-mediated mechanism, elicited by proteinaceous compounds in the food colour E 120.
The Panel noted that cases of severe allergic reactions, occurring after the consumption of carmine-containing foodstuffs, have been reported, and indicated that the information provided to alert individuals allergic to these colours is not sufficiently acted upon. The Panel considered that, since no threshold dose can be established for allergic reactions, it is advisable that exposure to the eliciting allergens, such as proteinaceous compounds, is avoided as much as possible. Therefore, the Panel considered that it may be advisable to reduce the presence of these allergens as much as possible by introducing appropriate purification steps to the manufacturing process.